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Review Pathway

Sponsors Of Two Orphans And An Acne Treatment To Defend Marketing Authorization Applications At EMA

Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.

EU Marketing Approval Gap Between Lilly’s Donamemab and Eisai’s Leqembi Could Narrow

The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.

New EU Filings Include First-Of-Its-Kind MS Drug Tolebrutinib & HIV Prophylaxis Lenacapavir

Several new drugs that are yet to be approved anywhere in the world are now under review by the European Medicines Agency for potential pan-EU marketing authorization.

Alvotech Eyeing US Aflibercept Biosimilar Approval This Year With FDA Acceptance

Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.

EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

New EU Filings

Doxecitine/doxribtimine, UCB’s investigational orphan drug for pediatric and adult patients with thymidine kinase 2 deficiency, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Navigating The Uncharted Waters Of EU HTA

The EU-level joint clinical assessments that will be introduced under the Health Technology Assessment Regulation from January 2025 represent a huge shift for drug companies launching products in the EU. Industry experts Alexander Natz and Matias Olsen offer key advice to help companies prepare for what is to come.

EMA PRIME Scheme: Two New Entries, 10 Rejections & One Withdrawal

A total of 141 products have made it onto the European Medicines Agency’s PRIME (priority medicines) scheme since 2016 and over 370 applications have been denied entry.

EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

New EU Filings

Elinzanetant, Bayer’s investigational treatment for hot flashes in menopausal women, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.